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Re: BTH post# 123437

Friday, 07/15/2011 7:57:30 PM

Friday, July 15, 2011 7:57:30 PM

Post# of 251706

If you do a post hoc analysis of a Phase 2 study in which the trial failed the primary endpoint, and find a subset that works, and then run a Phase 2b trial on that subset on, say, 100 patients, and the Phase 2b study confirms the drug is highly active in the subset, is that still an "illusion" or is this still merely considered post hoc, or, does the Phase 2b show results worthy of going forward, in your opinion?



I think if the P2b trial is randomized, then yes. This is not what's going on with Stimuvax, of course. They created a massive P3 program on a P2b subgroup analysis.

Unless otherwise indicated, this is the personal viewpoint of David
Miller and not necessarily that of Biotech Stock Research, LLC.
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